BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR

    MDR report key: 8979301 · Received September 10, 2019

    Report

    Report Number
    2133409-2019-00011
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 4, 2019
    Report Date
    May 4, 2020
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K110499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER PATIENT USER GUIDE SUP546, PATIENTS ARE PROVIDED WARNING STATEMENTS REGARDING ELECTRODE SKIN IRRITATION. PATIENTS ARE INSTRUCTED TO CONTACT (B)(4) CUSTOMER SUPPORT PRIOR TO USING THE MCT 3L MONITORING SYSTEM IF THEY HAVE KNOWN ALLERGIES TO NICKEL OR OTHER METALS. THE PATIENT IS ALSO INFORMED IN THE USER GUIDE THAT IF THEY DEVELOP SKIN IRRITATION THEY SHOULD CONTACT THEIR HEALTHCARE PROFESSIONAL. THE PATIENT DESCRIBED THE EXPERIENCED SKIN IRRITATION AS REDNESS, ITCHING, BLISTERS, AND WELTS AND SWELLING OF THE TONGUE. THE PATIENT INDICATED THAT THE IRRITATION PRIMARY LOCATION WAS THE ENTIRE ELECTRODE AREA. OTHER THAN ALLERGY TO NICKEL, SPECIFIC PATIENT INSTRINSIC, EXTRINSIC, AND PREVENTABLE FACTORS ARE UNKNOWN. THE PATIENT DID NOT CONSULT A CLINICIAN AND SELF-TREATED WITH BENADRYL (OTC), WITH NO FURTHER DETERIORATION. THE PATIENT DID NOT SEEK OR RECEIVE MEDICAL TREATMENT. THE PATIENT HAD STARTED MONITORING ON (B)(6) 2019, IRRITATION STARTED ON (B)(6) 2019 AND REPORTED ON 8/9/2019. THE PATIENT WAS PROVIDED ALTERNATE ELECTRODES ON 8/9/2019 AND WAS ABLE TO CONTINUE MONITORING WITH THE NEW ELECTRODES ON (B)(6) 2019. THE EVENT IS BEING REPORTED IN ALIGNMENT WITH PATIENT ALLEGATION OF "SWELLING OF THE TONGUE". THE PATIENT WAS ABLE TO CONTINUE MONITORING FOR ANOTHER EIGHT (8) DAYS WITH ALTERNATIVE NICKEL FREE ELECTRODES AND NO FURTHER ISSUES REPORTED AFTERWARDS. DEVICE HISTORY RECORD WAS REVIEWED, WITH NO CONTRIBUTING FACTORS IDENTIFIED. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME. CUSTOMER COMPLAINT WAS RELAYED TO ELECTRODE MANUFACTURER (3M) AND A RESPONSE WAS PROVIDED INDICATING THE FOLLOWING (REDACTED): THE RED DOT ELECTRODES HAVE BEEN SUBJECT TO A 3M BOARD CERTIFIED TOXICOLOGIST REVIEW AND HAVE BEEN SUBJECT TO BIOLOGICAL TESTING TO CONFIRM THEY ARE SAFE FOR THEIR ACCEPTABLE USE. IN ADDITION TO PERFORMING CLINICAL STUDIES, 3M MONITORS ITS MEDICAL DEVICES WITH MANUFACTURING CONTROLS SUCH AS: 1) RESIDUAL SOLVENT RELEASE SPECIFICATIONS AND TESTING. 2) ADHESIVE BASIS WEIGHT CONTROLS. 3) RETAIN SAMPLES. 4) FUNCTION RELEASE SPECIFICATIONS AND TESTING. DESPITE THESE STUDIES AND CONTROLS, THERE IS A PERCENTAGE OF THE POPULATION WHO ARE SENSITIVE OR WHO MAY BECOME SENSITIVE TO ADHESIVE PRODUCTS. THE PATIENTS MAY ALSO HAVE DELICATE SKIN TYPE OR SENSITIVITY TO SKIN PREP MATERIALS. TO MONITOR THESE SITUATIONS, MEDICAL COMPLAINTS ARE TRENDED TO ALLOW FOR APPROPRIATE CORRECTIVE ACTION TO BE TAKEN IF THE TREND DEVIATES FROM HISTORICAL VALUES. NO ADDITIONAL CONTRIBUTING FACTORS WERE IDENTIFIED UPON REVIEW OF THE SUPPLIER RESPONSE. NO ADDITIONAL INFORMATION IS KNOWN TO (B)(4), INC. AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2019, PATIENT NOTIFIED (B)(4), INC. OF SKIN IRRITATION/REACTION. THE SYMPTOMS DESCRIBED BY THE PATIENT INCLUDED "SWELLING OF THE TONGUE". NOTE: BECOME AWARE DATE IS (B)(6) 2019, PER COMPLAINT CASE GENERATED ((B)(4)).

    Additional Manufacturer Narrative · 1

    PER PATIENT USER GUIDE SUP546, PATIENTS ARE PROVIDED WARNING STATEMENTS REGARDING ELECTRODE SKIN IRRITATION. PATIENTS ARE INSTRUCTED TO CONTACT LIFEWATCH SERVICES CUSTOMER SUPPORT PRIOR TO USING THE MCT 3L MONITORING SYSTEM IF THEY HAVE KNOWN ALLERGIES TO NICKEL OR OTHER METALS. THE PATIENT IS ALSO INFORMED IN THE USER GUIDE THAT IF THEY DEVELOP SKIN IRRITATION THEY SHOULD CONTACT THEIR HEALTHCARE PROFESSIONAL. THE PATIENT DESCRIBED THE EXPERIENCED SKIN IRRITATION AS REDNESS, ITCHING, BLISTERS, AND WELTS AND SWELLING OF THE TONGUE. THE PATIENT INDICATED THAT THE IRRITATION PRIMARY LOCATION WAS THE ENTIRE ELECTRODE AREA. OTHER THAN ALLERGY TO NICKEL, SPECIFIC PATIENT INTRINSIC, EXTRINSIC, AND PREVENTABLE FACTORS ARE UNKNOWN. THE PATIENT DID NOT CONSULT A CLINICIAN AND SELF-TREATED WITH BENADRYL (OTC), WITH NO FURTHER DETERIORATION. THE PATIENT DID NOT SEEK OR RECEIVE MEDICAL TREATMENT. THE PATIENT HAD STARTED MONITORING ON (B)(6) 2019, IRRITATION STARTED ON (B)(6) 2019 AND REPORTED ON (B)(6) 2019. THE PATIENT WAS PROVIDED ALTERNATE ELECTRODES ON (B)(6) 2019 AND WAS ABLE TO CONTINUE MONITORING WITH THE NEW ELECTRODES ON (B)(6) 2019. THE EVENT IS BEING REPORTED IN ALIGNMENT WITH PATIENT ALLEGATION OF "SWELLING OF THE TONGUE". DEVICE HISTORY RECORD WAS REVIEWED, WITH NO CONTRIBUTING FACTORS IDENTIFIED. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2019, PATIENT NOTIFIED LIFEWATCH SERVICES, INC. OF SKIN IRRITATION/REACTION. THE SYMPTOMS DESCRIBED BY THE PATIENT INCLUDED "SWELLING OF THE TONGUE". NOTE: BECOME AWARE DATE IS (B)(6) 2019, PER COMPLAINT CASE GENERATED (CAS - (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773473 LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR DSI BRAEMAR MANUFACTURING, LLC MCT 3L 202105HA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other